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Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients | Clinical Trials | Clareo Health

RECRUITING

Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients

Generation of Induced Pluripotent Stem Cell Derived Cardiomyocytes From Patients Exposed to Trastuzumab Therapy for Breast Cancer

NCT02772367•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate whether cells from a biopsy taken from the patient skin can be transformed into cardiomyocytes the changes in cardiomyocyte (heart muscle cells) when grown in a special culture medium outside of the body. The structure and function of these cells will then be studied to determine why some patients with breast cancer who are treated with chemotherapy including anthracycline (e.g. Doxorubicin) and anti-HER2 therapy (e.g. Herceptin) develop decreased heart function.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female
•Age greater than 18 years
•Willing to participate in protocol procedures with signed informed consent
•Assessment of LVEE via echocardiogram, cardiac MRI, or MUGA
•Subjects in the cardiotoxicity group (TOX) must meet the following criteria:
•History of HER2 positive breast cancer (stage I-IV)
•Prior/current treatment with anthracycline based chemotherapy followed by anti-HER2 directed therapy or anti-HER2 directed therapy alone
•Assessment of LVEF at baseline prior to initiation of anthracycline or anti-HER2 therapy and during anti-HER2 therapy via echocardiogram, cardiac MRI, or MUGA
•Prior confirmed diagnosis of cardiotoxicity associated with anti-HER2 based therapy, defined as a decrease in LVEF \> 10% from baseline to \< 53% with symptoms of heart failure (NYHA class II-IV).
•Subjects in the no cardiotoxicity group (NO-TOX) must meet the following criteria:
+7 more criteria

Exclusion Criteria

•Unwilling or unable to give skin biopsies
•Contraindications to punch biopsy including but not limited to bleeding diathesis, as determined by the investigator.
•Known pre-existing CV disease prior to initiation of breast cancer therapy as determined by the investigator, including
•* Obstructive coronary artery disease (stenosis \>70%)
•* Arrhythmia - paroxysmal or persistent atrial arrhythmias, sustained ventricular tachycardia (\>30 seconds), ventricular fibrillation, or cardiac arrest
•* Cardiomyopathy (EF \<53%)
•* Heart failure (NYHA class II-IV)
•* Valvular heart disease with equal to or greater than moderate stenosis or regurgitation

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Key Dates

Start Date

May 11, 2016

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

July 16, 2025

Enrollment

120

ESTIMATED participants

Conditions

Breast Cancer

Interventions

skin punch biopsy

PROCEDURE

Contacts

Angel Chan, MD, PhD

CONTACT

212-639-7217 chana5@mskcc.org

Richard Steingart, MD

CONTACT

212-639-8488

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Generation of Heart Muscle Cells From Blood or Skin Cells of Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer